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Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel + oral Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer nodules or cysts (non-nodulocystic) during a 12-week treatment period.
This Phase 4, 12-week, single-arm, open-label, multi-center investigational efficacy and safety study was conducted in subjects with severe inflammatory acne. Subjects who met the inclusion criteria and none of the exclusion criteria at the Screening visit returned to the clinic for baseline measures (Week 0) and to start treatment, which continued for up to 12 weeks.
Treatment consisted of 2 investigational study drugs:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acne treatment | Experimental | Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel | Drug | Topical acne therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Inflammatory Lesions | Change in Number of Inflammatory Lesions from baseline. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percent of Subjects With IGA Success | IGA Success is defined as an IGA rating of Clear (Grade 0) or Almost Clear (Grade 1) | Weeks 4, 8, and 12 |
| Percent Change From Baseline in Total Lesion Count |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Laboratories, LP | Fort Worth | Texas | 76177 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29537444 | Derived | Del Rosso JQ, Stein Gold L, Johnson SM, Rueda MJ, Baldwin H, Lain EL, Landis M, Rendon M, Tanghetti E, Weiss J. Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Oral Doxycycline in Subjects With Severe Inflammatory Acne Who Are Candidates for Oral Isotretinoin. J Drugs Dermatol. 2018 Mar 1;17(3):264-273. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acne Treatment | Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets [50 mg], twice daily) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population, defined as all subjects who received at least one dose of a study drug, based on drug accountability data. Safety Population n = 175.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acne Treatment | Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets [50 mg], twice daily) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Number of Inflammatory Lesions | Change in Number of Inflammatory Lesions from baseline. | Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient. | Posted | Mean | Standard Deviation | Inflammatory lesions | Week 12 |
|
12 Weeks
Throughout the course of the study, all AEs were monitored and recorded along with date of onset, severity, relationship to study treatment, and outcome.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acne Treatment | Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks) Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel: Topical acne therapy Oral doxycycline hyclate: Tetracycline-class oral antibacterial 200 mg daily (2 tablets [50 mg], twice daily) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jean Philippe York, Medical Affairs Manager | Galderma Laboratories, LP | 1-817-961-5468 | jp.york@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2016 | Aug 2, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2016 | Aug 2, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D000068816 | Adapalene |
| D001585 | Benzoyl Peroxide |
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Oral doxycycline hyclate | Drug | Tetracycline-class oral antibacterial 200 mg daily (2 tablets [50 mg], twice daily) |
|
Percent Change From Baseline in Total Lesion Count.
| Weeks 4, 8, and 12 |
| Change From Baseline in Total Lesion Count | Change From Baseline in Total Lesion Count. | Weeks 4, 8, and 12 |
| Percent Change From Baseline in Inflammatory Lesion Count | Percent Change From Baseline in Inflammatory Lesion Count. | Weeks 4, 8, and 12 |
| Change From Baseline in Inflammatory Lesion Count | Change From Baseline in Inflammatory Lesion Count. | Weeks 4, 8, and 12 |
| Percent Change From Baseline in Non-Inflammatory Lesion Count | Percent Change From Baseline in Non-Inflammatory Lesion Count. | Weeks 4, 8, and 12 |
| Change From Baseline in Non-Inflammatory Lesion Count | Change From Baseline in Non-Inflammatory Lesion Count. | Weeks 4, 8, and 12 |
| Investigator's Evaluation: Number of Subjects Not Considered to be Oral Isotretinoin Candidates | At each visit, subjects were evaluated by the investigator to determine whether (in the opinion of the investigator) they would consider them as candidates for oral isotretinoin therapy. The outcome measure reports the number and % of subjects who, in the opinion of the investigator, were not considered to be "a candidate for oral isotretinoin therapy." | Weeks 0, 4, 8, and 12 |
| Subject Assessment of Acne Improvement | Subject Assessment of Acne Improvement on a 6 point scale (0 = Complete Improvement, 1 = Marked Improvement, 2 = Moderate Improvement, 3 = Minimal Improvement, 4 = No Change, 5 = Worse). | Week 12 |
| Number and Percent of Adverse Events | Number and percent of subjects with any Treatment-Related Adverse Event | Week 12 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| IGA 4 (Investigator's Global Assessment Score) | Investigator's Global Assessment Severity Scale IGA0 Clear------------Clear skin with no inflammatory/non-inflammatory lesions. IGA1 Almost Clear - A few scattered comedones and a few small papules. IGA2 Mild--------------Easily recognizable; less than half the face is involved. Some comedones and some papules/pustules. IGA3 Moderate-------More than half of the face is involved. Many comedones, papules/pustules. One small nodule may be present. IGA4 Severe----------Entire face is involved. Covered with comedones, numerous papules/pustules. Few nodules may or may not be present. | Count of Participants | Participants |
|
| Total Lesion Count | Mean | Standard Deviation | Lesion Count |
|
| Inflammatory Lesion Count | Mean | Standard Deviation | Lesion Count |
|
| Non-inflammatory Lesion Count | Mean | Standard Deviation | Lesion Count |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number and Percent of Subjects With IGA Success | IGA Success is defined as an IGA rating of Clear (Grade 0) or Almost Clear (Grade 1) | Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. | Posted | Count of Participants | Participants | Weeks 4, 8, and 12 |
|
|
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| Secondary | Percent Change From Baseline in Total Lesion Count | Percent Change From Baseline in Total Lesion Count. | Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient. | Posted | Mean | Standard Deviation | percent change in lesions | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Change From Baseline in Total Lesion Count | Change From Baseline in Total Lesion Count. | Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient. | Posted | Mean | Standard Deviation | change in lesions | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Percent Change From Baseline in Inflammatory Lesion Count | Percent Change From Baseline in Inflammatory Lesion Count. | Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient. | Posted | Mean | Standard Deviation | percent change in lesions | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Change From Baseline in Inflammatory Lesion Count | Change From Baseline in Inflammatory Lesion Count. | Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient. | Posted | Mean | Standard Deviation | change in lesions | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Percent Change From Baseline in Non-Inflammatory Lesion Count | Percent Change From Baseline in Non-Inflammatory Lesion Count. | Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient. | Posted | Mean | Standard Deviation | percent change in lesions | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Change From Baseline in Non-Inflammatory Lesion Count | Change From Baseline in Non-Inflammatory Lesion Count. | Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. Baseline lesion counts missing for one patient. | Posted | Mean | Standard Deviation | change in lesions | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Investigator's Evaluation: Number of Subjects Not Considered to be Oral Isotretinoin Candidates | At each visit, subjects were evaluated by the investigator to determine whether (in the opinion of the investigator) they would consider them as candidates for oral isotretinoin therapy. The outcome measure reports the number and % of subjects who, in the opinion of the investigator, were not considered to be "a candidate for oral isotretinoin therapy." | Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. | Posted | Count of Participants | Participants | Weeks 0, 4, 8, and 12 |
|
|
|
| Secondary | Subject Assessment of Acne Improvement | Subject Assessment of Acne Improvement on a 6 point scale (0 = Complete Improvement, 1 = Marked Improvement, 2 = Moderate Improvement, 3 = Minimal Improvement, 4 = No Change, 5 = Worse). | Intent-to-Treat (ITT) Population: The ITT Population consisted of the entire population enrolled at Baseline. All efficacy data were analyzed for the ITT Population. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
|
|
| Secondary | Number and Percent of Adverse Events | Number and percent of subjects with any Treatment-Related Adverse Event | The Safety Population consisted of the ITT Population following exclusion of subjects who never took the treatment with certainty, based on drug accountability data. All safety analyses were summarized for the Safety Population. | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| 0 |
| 175 |
| 0 |
| 175 |
| 22 |
| 175 |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
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| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
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| Week 12 |
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